Pharmaceutical companies walk a dangerous line with key opinion leaders (KOLs). Over the past five or six years, a much wider range of departmental and product groups have engaged KOLs in an ever-broader range of assignments. Discovery researchers ask doctors to foresee unmet needs in their specialties a decade down the road, while marketers want to know how a drug should be positioned over the final years of its lifecycle to remain a clinically effective—and profitable—product. From clinical-trials consultant and expert speaker to advisory board member, pharma's appetite for medical specialists keeps growing.

KOL Interactions with the Pharmaceutical Industry

However, the number of physicians available to play these roles cannot keep pace with demand. Inevitably, pharma turns to the same people again and again. At the same time, regulations—especially the guidelines released by OIG—threaten serious consequences for companies that seem to be offering quid pro quo compensation to their physician customers. To stay out of trouble, companies must learn who their KOLs are, how they fit the needs of different departments (siloed in larger companies), and how management can complete financial transactions within OIG guidelines.

Some KOLs Are Everywhere

As the same KOLs pop up in many different roles within the same company, one department or brand may have no idea what the others are doing. The potential exists for a company to unwittingly pay one opinion leader so much money that the relationship attracts unfavorable attention. If an opinion leader makes, say, 20 percent of his or her annual salary in consulting fees from one company, that organization can expect bad press and regulatory scrutiny.

Of course, companies have a legitimate need for advice from doctors who use their products. And sometimes, companies can easily keep track of their consultants. A leading manufacturer of orthopedic fixation devices, for instance, routinely invites leading orthopedic surgeons to its internal operating room to use the devices and offer feedback. The company is not too large, and it can keep track of who visits.

But companies with far-flung affiliates and rigid product and departmental silos are not so lucky. In a single therapeutic group, all marketers of three different heart medications may approach the same cardiologist for advice. The KOL may also be asked for his or her input at the discovery or clinical-trial stage of other company products. Before anyone at the company notices—that is, in the absence of centralized oversight—the doctor is collecting fees from five or six departments. He knows how much money is coming in, but the company may not know how much is going out.

Affiliates in other countries may also invite the same physician from the United States to speak at conferences. The result: Fees that are disbursed from cost centers around the globe, without the least accountability to one another, appear to an outside observer like OIG to come from one centralized, multinational corporation.

Companies need to understand which KOLs are working for them, and in what capacities. A Clarescent survey of global KOLs suggests that most KOLs participate in three to seven programs at once with a single pharmaceutical company. Often, the KOL knows the extent of his or her roles with a pharma company better than the company understands its deployment of the KOL.

Who Are the KOLs?

Key opinion leaders can be divided into classes based on how established they are, and how far their influence reaches. Some KOLs are well known. Others are emerging stars. They can be divided into established KOLs and up-and-comers. These groups are interesting for different reasons, but must be managed in similar ways.